Job Description

Job Summary: We are seeking a highly skilled and motivated individual to join our team as a Quality and Regulatory Affairs Manager. As a leading manufacturer of In Vitro Diagnostic (IVD) instruments and reagents, maintaining the highest standards of quality and compliance is of utmost importance to our organization. The successful candidate will be responsible for overseeing all aspects of quality control, quality assurance, and regulatory affairs to ensure our products meet the required standards and regulatory requirements. Responsibilities: - Develop and implement a comprehensive quality management system (QMS) to ensure compliance with applicable regulations and standards, such as ISO 13485 and MDR (India) 2017 requirements. - Manage the day-to-day operations of the quality control and quality assurance departments. - Conduct regular inspections, audits, and assessments to monitor and evaluate the effectiveness of quality processes and procedures. - Establish and maintain quality control documentation, including standard operating procedures (SOPs), work instructions, and quality records. - Coordinate with cross-functional teams to ensure proper implementation of quality control measures throughout the product lifecycle, from design and development to manufacturing and distribution. - Oversee the investigation and resolution of quality-related issues, non-conformities, and customer complaints, implementing corrective and preventive actions as necessary. - Stay updated on relevant regulatory requirements, industry standards, and best practices to ensure compliance in all aspects of product manufacturing, labelling, and documentation. - Prepare and submit regulatory submissions, technical files, and other documentation required for product approvals and registrations. - Serve as the primary point of contact for regulatory agencies and notified bodies, addressing inquiries, inspections, and audits including external audits. - Collaborate with R&D, manufacturing, and marketing teams to ensure new product development and launches comply with regulatory and quality requirements. - Conduct training programs and provide guidance to employees on quality systems, regulatory compliance, and best practices. - Manage the proper documentation and coordinate quality control for incoming raw material and outgoing finished goods. - Maintain all quality related records. Qualifications & requirements: - Bachelor\'s degree in a scientific or engineering discipline; advanced degree preferred. - Minimum of 3-4 years of experience in a quality control/assurance or regulatory affairs role within the medical device or IVD industry. - In-depth knowledge of quality management systems, regulatory requirements, and standards relevant to IVD instruments and reagents, such as ISO 13485 and MDR (India) 2017. - Strong understanding of quality control principles, statistical analysis, and continuous improvement methodologies. - Experience in managing regulatory submissions and interactions with regulatory agencies. - Excellent communication skills, both verbal and written, with the ability to effectively interact with internal teams, external stakeholders, and regulatory authorities. - Detail-oriented mindset with strong analytical and problem-solving abilities. - Ability to lead and motivate a team, ensuring collaboration, accountability, and a culture of quality excellence. Job Type: Full-time Salary: 9380,000.00 - 9700,000.00 per year Benefits:

• Food provided
• Paid sick time
• Paid time off

Schedule:

• Day shift

Supplemental pay types:

• Performance bonus
• Yearly bonus

Ability to commute/relocate:

• Gurugram, Haryana: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Quality Assurance: 1 year (Preferred)